Phase II Placebo-Controlled Randomized Discontinuation Trial of Sorafenib in Patients With Metastatic Renal Cell Carcinoma

• DOI: 10.1200/jco.2005.03.6723
• Publication Date: 2006-04-25T00:38:55Z
• Authors: Mark J. Ratain; Tim Eisen; Walter M. Stadler; Keith T. Flaherty; Stan B. Kaye; Gary L. Rosner; Martin Gore; Apurva A. Desai; Amita Patnaik; Henry Q. Xiong; Eric Rowinsky; James L. Abbruzzese; Chenghua Xia; Ronit Simantov; Brian Schwartz; Peter J. O'Dwyer
• Keywords: Discontinuation; Clinical endpoint; Tolerability

This phase II randomized discontinuation trial evaluated the effects of sorafenib (BAY 43-9006), an oral multikinase inhibitor targeting tumor and vasculature, on growth in patients with metastatic renal cell carcinoma.Patients initially received 400 mg twice daily during initial run-in period. After 12 weeks, changes bidimensional measurements that were less than 25% from baseline randomly assigned to or placebo for additional weeks; > = shrinkage continued open-label sorafenib; discontinued treatment. The primary end point was percentage remaining progression free at 24 weeks after initiation sorafenib.Of 202 treated period, 73 had 25%. Sixty-five stable disease (n 32) 33). At 50% sorafenib-treated versus 18% placebo-treated (P .0077). Median progression-free survival (PFS) randomization significantly longer (24 weeks) (6 P .0087). overall PFS 29 entire carcinoma population 202). Sorafenib readministered 28 whose progressed placebo; these until further progression, a median weeks. Common adverse events skin rash/desquamation, hand-foot reaction, fatigue; 9% therapy, no died toxicity.Sorafenib has significant disease-stabilizing activity is tolerable chronic therapy.